The Recall Desk

Archive

September 2021 recalls

519 recalls were announced in September 2021.

What the numbers show

Critical
6
Severe
98
High
317
Moderate
90
Low
8

Of the 519 recalls this month scored against our rubric, 1% are Critical, 19% are Severe.

301–400 of 519

  • HighNHTSA·21E086000·2021-09-14

    UFP Distribution Recalls WIC RV LPG Change Over Regulators

    UFP Distribution LLC is recalling specific WIC RV LPG change over regulators that may fail and increase propane pressure, posing a fire risk.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V710000·2021-09-14

    Kaufman Equipment Trailer Recall for Defective Locking Mechanism

    Kaufman Trailers is recalling 2021 Equipment trailers because a defective locking mechanism may cause the trailer to detach from the vehicle, increasing crash risk.

    Product
    KAUFMAN — KAUFMAN EQUIPMENT TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V709000·2021-09-13

    Altec Recalls 2021 Aerial Devices Due to Uncontrollable Boom Movement Risk

    Altec Industries is recalling 2021 AM50, 55, and 60E aerial devices because improperly machined cylinder rod threads may cause uncontrollable boom movement, increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·031-2021·2021-09-13

    SAS Foods Recalls Frozen Beef and Chicken Empanadas for False Inspection Mark

    SAS Foods Enterprises is recalling approximately 3,768 pounds of frozen beef and chicken empanadas produced without federal inspection and bearing a false USDA mark.

    Product
    SAS Foods Enterprises Inc. Recalls Frozen, Fully Cooked Beef and Chicken Empanada Products Packaged without Benefit of Inspection
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·21V708000·2021-09-13

    Keystone Hideout recreational vehicles recalled for propane regulator failure

    Certain 2020 Keystone Hideout recreational vehicles are recalled for faulty Winntec propane regulators that may fail and increase pressure, creating a fire risk in gas appliances. Dealers will replace the regulator free of charge.

    Product
    KEYSTONE — KEYSTONE, DUTCHMEN BULLET, COLEMAN, FUZION, KODIAK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V707000·2021-09-13

    2021 Audi E-Tron brake booster corrosion may disable braking systems

    Corrosion in the brake booster of certain 2021 Audi E-Tron vehicles may disable the Anti-Lock Brake System, Electronic Stability Control, and brake assist, increasing stopping distance and crash risk.

    Product
    AUDI — AUDI E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E085000·2021-09-13

    ZF Power Steering Pumps Recalled for Potential Loss of Assist

    ZF North America is recalling certain PS ED power steering pumps for Autocar and Spartan Fire vehicles due to a risk of losing power steering assist.

    Product
    STEERING:HYDRAULIC POWER ASSIST:PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V706000·2021-09-10

    2022 Nissan Pathfinder Hood Latch Bracket May Detach, Posing Crash Risk

    Nissan is recalling 2022 Pathfinder vehicles due to insufficient welds on the secondary hood latch bracket. The bracket may detach, allowing the hood to open if the primary latch fails, obstructing the driver's view and increasing crash risk.

    Product
    NISSAN — NISSAN PATHFINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V718000·2021-09-10

    Fox Factory Recalls Tuscany Kits for 2019-2021 Silverado and Sierra Trucks

    Fox Factory is recalling 2,646 trucks equipped with specific Tuscany Kits due to a risk of front wheel separation from ball joint failure.

    Product
    TUSCANY MOTOR CO — TUSCANY MOTOR CO CHEVROLET SILVERADO 1500, GMC SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V704000·2021-09-10

    Mercedes-Benz Recalls 2021 S 580 Vehicles for Fuel Pump Defect

    Mercedes-Benz is recalling 2021 S 580 vehicles because a loose fuel pump nozzle may cause engine stalls, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ S 580
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-09102021·2021-09-10

    FSIS Recalls Meat Snack Breadsticks Due to Misbranding and Undeclared Sesame Ingredient

    FSIS issued a public health alert for ready-to-eat breadsticks and meat and cheese snack packs from Jag Specialty Foods that were misbranded because sesame was not declared on the label.

    Product
    FSIS Issues Public Health Alert For Meat Snack Products Containing FDA-Regulated Breadstick Products That Have Been Recalled Due To Misbranding And An Undeclared Ingredient
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·21V702000·2021-09-10

    2022 GMC Acadia air bag system defect due to inactive safety module

    General Motors is recalling certain 2022 GMC Acadia vehicles with an unactivated sensing diagnostic module that prevents air bag deployment. The two affected units remain in dealer inventory.

    Product
    GMC — GMC ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21780·2021-09-09

    Teak shower benches recalled due to fall hazard and collapse risk

    Ivena teak shower benches sold at Costco can collapse during use, posing a fall hazard. Consumers have reported 81 incidents of collapse or breakage, including four injuries.

    Product
    Teak shower benches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V699000·2021-09-09

    2021 RAM ProMaster City Seat Belt Retractors May Fail to Secure Child Restraints

    Chrysler is recalling 2021 RAM ProMaster City and ProMaster vehicles because seat belt retractors may deactivate early, preventing child restraints from securing properly. This can increase injury risk during crashes.

    Product
    RAM — RAM PROMASTER, PROMASTER CITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21781·2021-09-09

    Vitus 14 and Vitus 16 Kids Bikes Recalled for Crash Hazard

    Wiggle Ltd. is recalling approximately 280 Vitus 14 and Vitus 16 kids bikes because they lack required footbrakes and may present a risk of injury to young children who cannot stop using handbrakes alone.

    Product
    VITUS 14 and VITUS 16 Kids Bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V698000·2021-09-09

    2021 RAM 1500 recalled for incorrect spare tire installation

    Chrysler is recalling 2021 RAM 1500 vehicles with an incorrect-size spare tire that does not match the placard specifications. Improper tire inflation could increase the risk of crashes.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V700000·2021-09-09

    Newmar Recreational Vehicles: Instrument Cluster May Go Blank While Driving

    Newmar is recalling certain 2019-2021 recreational vehicles because the instrument cluster may intermittently go blank while driving, potentially hiding critical information like vehicle speed and warning lights.

    Product
    NEWMAR — NEWMAR KING AIRE, MOUNTAIN AIRE, LONDON AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·21194·2021-09-09

    Janod Children's Shaving Kits Recalled for Excessive Phthalate Levels

    Juratoys is recalling about 13,600 Janod Children's Shaving Kits because the brown trim on the bags contains banned phthalates in excess of federal limits. Consumers should stop using the kit and return it for a full refund.

    Product
    Janod Children's Shaving Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·21779·2021-09-09

    Burley Ballz QR Skewers Recalled Due to Fall Hazard

    Burley Design is recalling Ballz QR Skewers, which attach cargo trailers to bicycles, because the skewer can shear or bend, potentially destabilizing the trailer and bicycle and causing the rider to fall.

    Product
    Ballz QR Skewers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0893-2021·2021-09-08

    BrightFarms Spring Crunch Lettuce Recall Due to Salmonella Risk

    BrightFarms Spring Crunch lettuce packaged in 4oz clear plastic clamshells may be contaminated with Salmonella. The recall affects products distributed in Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Spring Crunch; packaged in clear, plastic clamshells; 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0890-2021·2021-09-08

    BrightFarms Harvest Crunch Salmonella Contamination Recall

    BrightFarms Harvest Crunch packaged salad may be contaminated with Salmonella. The recall affects products distributed in Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Harvest Crunch; packaged in clear plastic clamshells; 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0895-2021·2021-09-08

    BrightFarms Nutrigreens Recalled for Potential Salmonella Contamination

    BrightFarms Nutrigreens 3oz packages may be contaminated with Salmonella. The product was grown at the company's Rochelle, Illinois indoor farm and distributed across Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Nutrigreens; packaged in clear, plastic clamshells; 3oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0901-2021·2021-09-08

    Cahill Cheddar with Porter Cheese Recalled for Listeria Contamination Risk

    Whole Foods Market is recalling Cahill Cheddar with Porter cheese (PLU 93579) sold in clear plastic packaging due to potential contamination with Listeria monocytogenes, a serious foodborne pathogen.

    Product
    Cahill Cheddar with Porter PLU 93579 packaged in clear plastic
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Food)·F-0892-2021·2021-09-08

    BrightFarms Lakeside Crunch Salad Recalled for Potential Salmonella Contamination

    BrightFarms Lakeside Crunch salad, sold in 4oz packages, is being recalled due to potential Salmonella contamination. The product was distributed across Illinois, Wisconsin, Iowa, Indiana, and Michigan.

    Product
    BrightFarms Lakeside Crunch; packaged in clear, plastic clamshell; 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0781-2021·2021-09-08

    Hand Sanitizer Gel Recalled for Methanol Contamination and Low Ethanol

    MEDICALLY MINDED Hand Sanitizer Gel (Ethyl Alcohol 70%) distributed nationwide has been recalled after FDA testing found methanol contamination and ethanol content below label claims. Consumers should stop using the product.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0897-2021·2021-09-08

    BrightFarms Spinach Recall Due to Potential Salmonella Contamination

    BrightFarms Spinach packaged in 4oz and 8oz clamshells may be contaminated with Salmonella. The affected product was grown at the company's Rochelle, Illinois indoor farm and distributed across multiple Midwest states.

    Product
    BrightFarms Spinach; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0888-2021·2021-09-08

    BrightFarms Sunny Crunch Lettuce Recalled for Salmonella Risk

    Bright Farms is recalling BrightFarms Sunny Crunch lettuce sold in 4oz and 8oz plastic clamshells because the product may be contaminated with Salmonella.

    Product
    BrightFarms Sunny Crunch; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0894-2021·2021-09-08

    BrightFarms Butter Crisp Lettuce Recalled for Salmonella Risk

    BrightFarms Butter Crisp lettuce packaged in 4-oz clear plastic clamshells is being recalled due to potential Salmonella contamination. The product was distributed in Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Butter Crisp; packaged in clear, plastic clamshells; 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0782-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (Ethyl Alcohol 70% v/v, 8.5 FL OZ / 250 mL) distributed nationwide due to manufacturing conditions that led to methanol contamination in product lots.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V697000·2021-09-08

    2021 Porsche Taycan: Brake booster defect may cause brake pedal failure

    Certain 2021 Porsche Taycan vehicles have a loose pressure input rod connection on the brake booster that may detach, causing brake pedal failure and increasing crash risk. Dealers will repair or replace the brake booster free of charge.

    Product
    PORSCHE — PORSCHE 911 CARRERA, TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0783-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Manufacturing Deviations

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (70% ethyl alcohol, 8 fl oz bottles) distributed nationwide due to manufacturing deviations under conditions that produced a methanol-contaminated product lot.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0778-2021·2021-09-08

    Hand Sanitizer Gel Recalled Due to Methanol Contamination Risk

    Global Sanitizers LLC is recalling MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel (70% ethyl alcohol) due to manufacturing deviations. Products were made under the same conditions as a lot found to contain methanol.

    Product
    MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0932-2021·2021-09-08

    Spicy Shrimp Tempura Roll recalled for Salmonella contamination

    Mai Cuisine's 12 PC Spicy Shrimp Tempura Roll is being recalled due to Salmonella contamination in frozen shrimp used in the product. The recall affects approximately 1,490 packages sold at Genji Sushi counters inside Whole Foods Market stores in Northern California.

    Product
    12 PC Spicy Shrimp Tempura Roll [WR] UPC: 81244803385 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0779-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (8.5 FL OZ) due to potential methanol contamination. The product was manufactured under the same conditions as a lot previously found to contain methanol.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Ma
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0780-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel recalled for methanol contamination

    The FDA found one lot of MEDICALLY MINDED Hand Sanitizer Gel to contain methanol and fall below the labeled ethanol content. The product was distributed nationwide.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made i
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0902-2021·2021-09-08

    Cahill Whiskey Cheddar Cheese Recalled for Potential Listeria Contamination

    Whole Foods Market is recalling Cahill Whiskey Cheddar Cheese due to potential contamination with Listeria monocytogenes. The cheese was distributed to stores across multiple states from May to July 2021.

    Product
    Cahill Whiskey Cheddar Cheese packaged in clear plastic PLU 5478494884
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Food)·F-0896-2021·2021-09-08

    BrightFarms Mighty Romaine Recalled for Potential Salmonella Contamination

    BrightFarms is recalling Mighty Romaine lettuce sold in 4oz and 8oz clamshells because the product may be contaminated with Salmonella.

    Product
    BrightFarms Mighty Romaine; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0891-2021·2021-09-08

    BrightFarms 50/50 Spring & Spinach Salmonella Contamination Recall

    BrightFarms 50/50 Spring & Spinach in 4oz clamshells may be contaminated with Salmonella. The product was distributed in Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms 50/50 Spring & Spinach; packaged in clear plastic clamshells, 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0889-2021·2021-09-08

    BrightFarms Spring Mix Recalled Due to Salmonella Risk

    BrightFarms Spring Mix sold in 4oz and 8oz clamshells may be contaminated with Salmonella. The product was distributed across Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Spring Mix; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2388-2021·2021-09-08

    Surgical arm suspension kits recalled due to sterilization concerns

    Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.

    Product
    Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0942-2021·2021-09-08

    Spicy Shrimp Inari Sushi recalled for Salmonella contamination

    Mai Cuisine is recalling Spicy Shrimp Inari 4 PC sushi products sold at Whole Foods Market Genji Sushi counters in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Spicy Shrimp Inari 4 PC [WR] UPC: 81244803399 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·21V696000·2021-09-08

    Blue Bird Recalls 2022 Vision School Buses for Camera Obstruction

    Blue Bird is recalling 2022 Vision school buses because the collision mitigation camera may block the driver's view of the passenger side cross-view mirror, increasing pedestrian injury risk.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21C004000·2021-09-08

    Dorel Maxi-Cosi Pria 70 Child Seat Recall for Tether Anchor Defect

    Dorel Juvenile Group is recalling Maxi-Cosi Pria 70 convertible child seats because they may not adequately protect children from head injury in a crash if installed without a top tether.

    Product
    CHILD SEAT:VEHICLE TETHER ANCHOR recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0935-2021·2021-09-08

    Ono Shrimp Poke Bowl Recalled for Salmonella Contamination

    Mai Cuisine is recalling Ono Shrimp Poke Bowl products sold at Genji Sushi counters in Whole Foods Market stores due to Salmonella contamination in frozen shrimp used in the sushi products.

    Product
    ONO SHRIMP POKE BOWL UPC:84003140699 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2398-2021·2021-09-08

    Medical Device Recall: TruMatch CT Cut Guide Kit Software Misalignment Error

    DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during surgery.

    Product
    TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2395-2021·2021-09-08

    Surgical instrument software error may cause limb misalignment

    DePuy Orthopaedics' TruMatch CT Pin Guide Kit has a software coding error that may misalign bone landmarks during joint replacement surgery, potentially causing limb malalignment. No injuries have been reported.

    Product
    TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2382-2021·2021-09-08

    FDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk

    Thera Test Laboratories is recalling EL-Anti-SARS-CoV-2 IgG kits due to cross-reactivity that may produce false positive results. The recalled lot numbers are 05204351 and 05204368, affecting distribution in six US states.

    Product
    EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2381-2021·2021-09-08

    COVID-19 Antibody Test Kit Recalled for Failing Validation Requirements

    Thera Test Laboratories is recalling 11 EL-Anti-SARS-CoV-2 IgM test kits distributed across six states because they failed to meet FDA's updated validation requirements for accurately detecting COVID-19 antibodies.

    Product
    EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2387-2021·2021-09-08

    Merge Hemo Software Recall Due to HL7 Lab Interface Safety Issue

    Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.

    Product
    Merge Hemo, Software packages 10.2, 10.3, and 10.4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2405-2021·2021-09-08

    Discectomy Device Kit Class II recall due to sterile barrier compromise

    Clarus Medical recalls the Lase Discectomy Device Kit due to potential compromise of the sterile barrier seal. Approximately 858 units were distributed in the US and internationally.

    Product
    Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0789-2021·2021-09-08

    China-Gel Topical Pain Reliever Recalled for Manufacturing Facility Contamination

    China-Gel Inc is recalling China-Gel White topical pain reliever products due to potential contamination with Burkholderia cepacia found at the manufacturing facility. The recall affects multiple package sizes distributed nationwide and internationally.

    Product
    CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2021·2021-09-08

    TruMatch CT Surgical Guidance Software Misalignment in Joint Replacement Instruments

    DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2380-2021·2021-09-08

    Surgical Instrument Recall: Failed Adhesive May Cause Tissue Burns

    Olympus recalls Gyrus Acmi PKS surgical instruments due to expired adhesive that could fail, potentially causing foreign body reactions or electrical burns to patients.

    Product
    Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2021·2021-09-08

    DePuy TruMatch CT Cut Guide Kit Recalled for Software Alignment Error

    DePuy's TruMatch CT Cut Guide Kit is being recalled due to a software coding error that may cause misalignment of preoperative surgical positioning scans, potentially resulting in improper limb alignment during joint replacement surgery.

    Product
    TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number:
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Drugs)·D-0788-2021·2021-09-08

    China-Gel Topical Pain Reliever Recall Due to Manufacturing Contamination

    China Gel Inc is recalling China-Gel (menthol and camphor) topical pain reliever products due to contamination with B. cepacia found in the manufacturing facility where the product was made.

    Product
    CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0790-2021·2021-09-08

    Topical Pain Relief AULIEF Recalled for Facility Contamination Risk

    China Gel Inc is recalling AULIEF topical pain relief (menthol and camphor) because the product was manufactured in a facility where Burkholderia cepacia contamination was found in other products.

    Product
    AULIEF — AULIEF (MENTHOL AND CAMOHOR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2021·2021-09-08

    Peripheral Atherectomy Devices Recalled Due to Crown Size Mislabeling

    Cardiovascular Systems Inc is recalling STEALTH 360 GEN2 peripheral atherectomy devices due to potential mislabeling of crown sizes. Some 1.50mm crowns may be labeled as 1.25mm and vice versa, potentially affecting device performance.

    Product
    STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2021·2021-09-08

    Monaco RTP System software defect may cause incorrect radiation therapy dose calculations

    Elekta's Monaco RTP System software (builds 5.40.00, 5.40.01, 5.40.02, 5.51.10) may calculate incorrect radiation doses if a treatment couch is removed and reinserted during specific plan loading operations.

    Product
    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2410-2021·2021-09-08

    COVID-19/Flu Rapid Test Distributed to Non-Certified Laboratories

    COVID-19/Flu rapid diagnostic test was distributed to laboratories not certified under federal clinical standards. The 563,290-unit recall affects nationwide distribution; products were authorized only for CLIA-certified laboratories.

    Product
    Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0776-2021·2021-09-08

    Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination

    Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg (4,992 bottles, batch 1408824A, expiration 08/2023) distributed nationwide due to out-of-specification microbial test results in an excipient ingredient.

    Product
    Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2021·2021-09-08

    Baxter Prismaflex Dialysis Membranes Recalled for Sterilization Failure

    Baxter is recalling Prismaflex HF 1000 dialysis membranes (Lot 20B2330M) because products labeled as sterile may not have been properly sterilized due to manufacturing defects and data manipulation. Non-sterile devices could pose infection risks to patients.

    Product
    Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0958-2021·2021-09-08

    Hostess Soft White Hot Dog Buns Recalled for Listeria and Salmonella Risk

    Hostess Brands is recalling Soft White Hot Dog Buns due to positive environmental samples for Listeria and Salmonella found by the contract manufacturer. The product was distributed to retailers and distributors across 34 U.S. states.

    Product
    Hostess Soft White Hot Dog Buns, Net Wt. 12 OZ, UPC 888109110970
    Category
    Food
    Distribution
    35 states
  • HighFDA (Food)·F-0938-2021·2021-09-08

    Shrimp California Roll Recall Due to Salmonella Contamination

    Mai Cuisine is recalling Shrimp California Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Shrimp California Roll [BR] UPC: 81244803702 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0944-2021·2021-09-08

    Spicy Shrimp Tempura Roll Recalled for Salmonella Contamination

    Mai Cuisine is recalling Spicy Shrimp Tempura Roll products sold at Whole Foods Market Genji Sushi counters in Northern California due to Salmonella contamination in the frozen shrimp used to prepare the sushi.

    Product
    Spicy Shrimp Tempura Roll [WR] UPC: 81244803443 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0933-2021·2021-09-08

    Genji Sushi Products Recalled for Salmonella Contamination

    Mai Cuisine is recalling approximately 1490 packages of August Box of the Month sushi products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination from frozen shrimp used in the products.

    Product
    August Box of the Month NCA UPC: 84003140261 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0950-2021·2021-09-08

    Chef's Assorted Nigiri 6PC recalled for Salmonella contamination

    Mai Cuisine is recalling Chef's Assorted Nigiri 6PC sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the sushi products.

    Product
    CHEF'S ASSORTED NIGIRI 6PC UPC: 81282401130 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0954-2021·2021-09-08

    Mai Cuisine Shrimp Mango Fresh Rolls recalled for Salmonella contamination

    Mai Cuisine is recalling Shrimp Mango Fresh Rolls sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in the frozen shrimp used in the product.

    Product
    SHRIMP MANGO FRESH ROLL UPC:81282401374 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0943-2021·2021-09-08

    Spicy Shrimp Inari sushi recalled for potential Salmonella contamination

    Mai Cuisine is recalling Spicy Shrimp Inari 4pc Kabuki sushi sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Spicy Shrimp Inari 4pc Kabuki [WR] UPC: 81244803408 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0936-2021·2021-09-08

    Rainbow Sushi Set recalled due to Salmonella in frozen shrimp

    Mai Cuisine's Rainbow Sushi Set sold at Whole Foods Market Genji Sushi counters in Northern California is being recalled because frozen shrimp used in the product was contaminated with Salmonella.

    Product
    Rainbow Sushi Set [WR] UPC:81244803418 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0903-2021·2021-09-08

    Strawberry Yogurt Granola Parfait Recalled for Undeclared Soy

    Loffredo Fresh Gardens Inc. is recalling Strawberry Yogurt Granola Parfait products sold under multiple brands because soy lecithin in the yogurt ingredient is not declared on the label, posing a risk to consumers with soy allergies.

    Product
    Strawberry Yogurt Granola Parfait packaged in clear plastic cups and labeled in the following ways: 1) Go Fresh Market Strawberry Granola Yogurt, Net wt. 6.5 oz (184 g), UPC 7 58870 32670 5, Distributed by Produce Innovation, Norwalk, IA; 2) HWY 28 Farms, Strawberry Yogurt
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0904-2021·2021-09-08

    Your Way Fresh Yogurt Parfait Recalled for Undeclared Soy

    Your Way Fresh Sliced Banana + Strawberry Yogurt Parfait is being recalled because the yogurt ingredient contains soy lecithin, but soy is not declared on the product label. Consumers with soy allergies may face serious health risks.

    Product
    Your Way Fresh, Sliced Banana + Strawberry Yogurt Parfait; Net wt. 6.25 oz (177 g); UPC 8 54426 00807 8; Distributed by Your Way Fresh, Newport Beach, CA, 12 cups per case;
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0941-2021·2021-09-08

    Spicy Shrimp California Roll Recalled for Salmonella Contamination

    Mai Cuisine is recalling Spicy Shrimp California Roll sushi products sold at Whole Foods Market Genji Sushi counters in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Spicy Shrimp California Roll [WR] UPC: 81244803444 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0939-2021·2021-09-08

    Shrimp California Roll recalled for Salmonella contamination

    Mai Cuisine is recalling Shrimp California Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Shrimp California Roll [WR] UPC: 81244803442 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0957-2021·2021-09-08

    Hostess Soft White Hamburger Buns Recalled for Listeria and Salmonella Risk

    Hostess Brands, LLC is recalling Hostess Soft White Hamburger Buns because the contract manufacturer detected positive environmental samples for Listeria and Salmonella species. The affected product was distributed to retailers and distributors across 34 states.

    Product
    Hostess Soft White Hamburger Buns, Net Wt. 12 OZ, UPC 888109110987
    Category
    Food
    Distribution
    35 states
  • HighFDA (Food)·F-0940-2021·2021-09-08

    Shrimp Summer Roll Recall Due to Salmonella Contamination

    Mai Cuisine is recalling Shrimp Summer Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp used to make the sushi products.

    Product
    Shrimp Summer Roll UPC:81282401393 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0949-2021·2021-09-08

    Mai Cuisine Sushi Sets Recalled for Salmonella in Shrimp

    Mai Cuisine is recalling Special Roll Super Set 16-piece sushi products sold at New Leaf Community Market locations in Northern California due to Salmonella contamination in frozen shrimp used in the products.

    Product
    SPECIAL ROLL SUPER SET 16PC UPC: 81282401129 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0951-2021·2021-09-08

    Mai Cuisine Scorpion Roll Sushi Recalled for Salmonella

    Mai Cuisine is recalling Scorpion Roll sushi sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the product. The affected products were hand-crafted on 8/12/2021 and 8/13/2021.

    Product
    SCORPION ROLL UPC:81282401138 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2390-2021·2021-09-08

    Norton Arm Kit surgical device recall due to sterilization failure

    Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.

    Product
    Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0946-2021·2021-09-08

    Wok st. Shrimp Lo Mein Recalled for Salmonella Contamination

    Mai Cuisine is recalling Wok st. Shrimp Lo Mein (UPC 84003140405) sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Wok st. Shrimp Lo Mein UPC: 84003140405 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0786-2021·2021-09-08

    Akorn Artificial Tears Ointment Recalled for Non-Sterility

    Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.

    Product
    Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2021·2021-09-08

    TruMatch Surgical Instruments Recalled for Software Alignment Error

    DePuy Orthopaedics recalls TruMatch patient-specific surgical instruments due to a Fast3D software error that may misalign scanning images, potentially causing limb malalignment during surgery.

    Product
    TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0947-2021·2021-09-08

    Mai Cuisine Shrimp Tempura Kabuki Roll recalled for Salmonella

    Mai Cuisine is recalling 12-piece Shrimp Tempura Kabuki Roll sold at Target Mai Sushi counters in Northern California because the frozen shrimp used in the product may be contaminated with Salmonella.

    Product
    12pc Shrimp Tempura Kabuki Roll WR UPC: 8 4003140626 2 Product was sold from Mai Sushi counters inside Target stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0948-2021·2021-09-08

    Mai Cuisine Spicy Shrimp Tempura Roll Recalled for Salmonella

    Mai Cuisine is recalling Spicy Shrimp Tempura Roll sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    SPICY SHRIMP TEMPURA ROLL UPC: 81282401109 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0952-2021·2021-09-08

    BR Special Roll Super Set Sushi Recalled for Salmonella Risk

    Mai Cuisine is recalling BR Special Roll Super Set 16-piece sushi products sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the product.

    Product
    BR SPECIAL ROLL SUPER SET 16PCL UPC:81282401203 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1016-2021·2021-09-08

    Rocky Top Farms Cherry Butter recalled for undeclared milk allergen

    Rocky Top Farms Cherry Butter is being recalled because it contains undeclared milk, which can pose a serious risk to consumers with milk allergies. The recall affects retail and food service packages.

    Product
    Rocky Top Farms Cherry Butter sold in 1 gallon food service and 10oz retail sizes. 10 oz retail units may be sold individually and as multi-pack and variety packs online.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0934-2021·2021-09-08

    Double Shrimp BBQ Roll recalled due to Salmonella contamination

    Mai Cuisine is recalling Double Shrimp BBQ Roll sushi products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    Double Shrimp BBQ Roll WR UPC: 81244803204 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0930-2021·2021-09-08

    Shrimp Tempura Kabuki Roll Recalled for Salmonella Contamination

    Mai Cuisine is recalling 12 PC Shrimp Tempura Kabuki Roll products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp used in these products.

    Product
    12 PC Shrimp Tempura Kabuki Roll [BR] UPC: 81244803670 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0945-2021·2021-09-08

    WOK ST SHRIMP VEGGIE LO MEIN recalled for Salmonella contamination

    Mai Cuisine is recalling WOK ST SHRIMP VEGGIE LO MEIN sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in the frozen shrimp ingredient.

    Product
    WOK ST SHRIMP VEGGIE LO MEIN P UPC: 84003140247 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0905-2021·2021-09-08

    Your Way Fresh Greek Yogurt Peach Parfait recalled for undeclared soy

    Your Way Fresh Greek Yogurt + Peach Parfait is being recalled because soy lecithin in an ingredient is not declared on the label, posing a risk to consumers with soy allergies.

    Product
    Your Way Fresh, Greek Yogurt + Peach Parfait; Net wt. 6.25 oz (177 g); UPC 8 54426 00809 2; Distributed by Your Way Fresh, Newport Beach, CA, 12 cups per case;
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0931-2021·2021-09-08

    Shrimp Tempura Kabuki Roll recalled for Salmonella contamination

    Mai Cuisine is recalling 12 PC Shrimp Tempura Kabuki Roll sushi products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the products.

    Product
    12 PC Shrimp Tempura Kabuki Roll [WR UPC:81244803410 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0937-2021·2021-09-08

    Sushi Products Recalled Due to Salmonella in Frozen Shrimp

    Mai Cuisine is recalling sushi products sold at Genji Sushi counters in Northern California Whole Foods Markets due to Salmonella contamination in frozen shrimp used as an ingredient. Products with hand-crafted dates of 8/12/2021 or 8/13/2021 are affected.

    Product
    Sept Box of The Month (NCA) WR UPC: 84003140397 Products were sold from Genji Sushi counters inside Whole Foods Market stores
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0953-2021·2021-09-08

    Mai Cuisine Cooked Variety Pack Recalled for Salmonella in Frozen Shrimp

    Mai Cuisine is recalling Cooked Variety Pack sushi products sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the products.

    Product
    COOKED VARIETY PACK UPC:81282401349 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2404-2021·2021-09-08

    Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment

    Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.

    Product
    Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2021·2021-09-08

    Medical Imaging Software Bug May Cause Incorrect X-ray Exposure

    Philips CombiDiagnost R90 imaging software has a bug where exposure settings may change unexpectedly, resulting in over or under-exposed X-ray images. About 66 systems in the US are affected.

    Product
    CombiDiagnost R90 Software Version R1.0 and R1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2021·2021-09-08

    Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure

    Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.

    Product
    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismafl
    Category
    Medical Device
    Distribution
    Distributed nationwide

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